Manager Regulatory Affairs at Cencora

, , Vietnam -

Full Time

Start Date

Immediate

Expiry Date

29 Jul, 26

Salary

0.0

Posted On

30 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Lifecycle Management, Dossier Compilation, Chemistry Manufacturing & Controls, Regulatory Compliance, Labelling, Submission Strategy, Regulatory Intelligence, Product Maintenance, Quality Assurance, Safety Reporting, Stakeholder Management, Promotional Material Review, Health Authority Liaison, Cross-functional Communication

Industry

Hospitals and Health Care

Description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. Responsibilities: Regulatory Affairs activities for lifecycle management of pharmaceutical products including but not limited to: Support change applications (Administrative, Labelling, Chemistry Manufacturing & Controls, Safety) including submission strategy Dossier compilation including preparation of documents (e.g. local forms, Cover Letters) and Table of Contents Content review of Chemistry, Manufacturing & Controls/Labelling documentation/Justification documents Alignment with functions on variation procedures, deficiency letter, e.g, Chemistry Manufacturing Controls, Medical Science, publishing team Update/local Product Information (Labelling translation) Check regulatory compliance of product information/artworks Marketing Authorization withdrawal Marketing Authorization Holder transfer Licence renewal . Other Accountabilities: Periodic Safety Update Report contribution Invoice check (e.g. Authority invoices) Request Translation/additional Module 1 documents, e.g. Quality Practices declaration, Good Manufacturing Practices Databases maintenance: archiving, tracking Management of local Regulatory Affairs requirements (local regulatory intelligence) National Competent Authorities electronic systems for submission as locally required Contact with the local Health Authority on behalf of the client Cross-functional communication to all relevant departments in relation to regulatory strategy and submission as well as issues related to Lifecycle Management activities Support of Country Regulatory Affairs Head in issue management (e.g. Product Quality Controls Standards Quality, Safety issues like stock out situations management, Dear Healthcare Professional Letter preparation coordination and submission in accordance with local regulations and company Standard Operating Procedures, represent Regulatory Affairs in internal meetings and committees) Review of Promotional Materials What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex Australia Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health. Recruitment scams are on the rise and the intent is to target individuals looking for employment opportunities. To protect yourself, we urge you to be vigilant and follow these guidelines. 1.) Research the Company: Thoroughly research any company before applying or sharing personal information, check their website, read reviews, and verify their legitimacy. 2.) Be Wary of Unrealistic Promises: Exercise caution If a job posting offers high salaries and minimal qualifications. Legitimate jobs will have realistic expectations and provide detailed job requirements. Jobs at Cencora can be found on Cencora.com/careers 3.) Guard Your Personal Information: Only share sensitive information after vetting the employer’s credibility. Avoid sharing your Social Security number, bank account details, or identification documents during the application process. Cencora does not request this information as part of the employment application. 4.) Avoid Upfront Payments: Legitimate employers do not require payment during the hiring process. Be suspicious if you are asked to pay for training materials, processing fees, or background checks before securing a job offer. Cencora will never ask you for payment information during the hiring or onboarding process. 5.) Verify Communication Channels: Scammers often use free email services or chat platforms without providing an official company contact information. Cencora recruiters will have an email address ending in @cencora.com, @alliance-healthcare.net, @alliance-healthcare.co.uk, alliance-healthcare.fr or alliance-healthcare.ro Remember to stay vigilant and informed about common scam tactics to reduce the risk of falling victim to fraudulent employment schemes. If you believe you have encountered a job scam posing as a Cencora opportunity, please report it immediately to: GlobalTalentAcquisition@Cencora.com

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Responsibilities

The Manager of Regulatory Affairs will oversee lifecycle management activities, including dossier compilation, submission strategy, and regulatory compliance for pharmaceutical products. They will also serve as a primary contact for local health authorities and provide cross-functional support for quality and safety issues.